Vincristine Sulfate Liposome Phase ? Clinical Efficacy And Safety Study

Vincristine sulfate system broad-spectrum anticancer drug,has exact therapeutic effect on acute lymphoblastic leukemia,for decades the clinical studies verify that a large number of domestic and foreign,is one of the important first-line drugs for acute lymphoblastic leukemia induction chemotherapy.The main adverse reaction was to peripheral nerve injury,the most common manifestation is tingling numbness,moderate,serious when can cause muscle atrophy,muscle weakness,intestinal obstruction.Peripheral nerve occurrence rate can reach more than 50%.Although most patients with peripheral neurotoxicity is not serious,but the neural cell line permanent cell,repair is very slow,long endure the discomfort of patients,impact quality of life.Peripheral nerve injury and peripheral sensory nerve injury rate is highest,the strongest specificity.Liposome is targeting a new drug delivery system,a class of cell structure,can change the distribution of encapsulated drugs in vivo.There is similarity and histocompatibility of the lipid bilayer and biofilm,easy to be absorbed in order to improve the therapeutic index,reduce the dose of drugs,reduce the toxicity of drugs.Therefore,with the development and application of vincristine sulfate liposome injection,so as to improve the tolerance and efficacy of vincristine sulfate,reduce toxicity,better clinical applications.The effectiveness and safety of the main subject of this paper for injection with chemotherapy regimen of vincristine sulfate liposomes combined treatment of adult acute lymphoblastic leukemia phase III clinical research,main purpose is to test the incidence of further evaluation Vincristine Sulfate for Injection liposome in the treatment of acute lymphoblastic leukemia effect and peripheral neurotoxicity,secondary objective was to further evaluate the safety Vincristine Sulfate for Injection liposome in the treatment of acute lymphoblastic leukemia.At present,vincristine sulfate liposome in phase I and II clinical trials of many domestic and foreign companies are ongoing,clinical trial results are good.Experimental design involved in this article is a multi center,double-blind,phase III clinical trial randomized,parallel group,subjects for adult patients with acute lymphoblastic leukemia,the main research content is to vincristine sulfate liposomes as the main experimental drugs to other drug combination regimens,as well as the evaluation index and statistical the analysis results for further evaluation in phase III clinical efficacy and safety of vincristine sulfate liposomes.